U.S. patent number 7,066,942 [Application Number 10/679,077] was granted by the patent office on 2006-06-27 for bendable needle for delivering bone graft material and method of use.
This patent grant is currently assigned to Wright Medical Technology, Inc.. Invention is credited to John T. Treace.
United States Patent |
7,066,942 |
Treace |
June 27, 2006 |
Bendable needle for delivering bone graft material and method of
use
Abstract
A bone graft needle, particularly useful in minimally invasive
procedures, is provided. The bone graft needle as well as its
corresponding penetrating member may be made from bendable
materials so that the combined instrument can more easily access
hard to reach areas of the body.
Inventors: |
Treace; John T. (Germantown,
TN) |
Assignee: |
Wright Medical Technology, Inc.
(Arlington, TN)
|
Family
ID: |
32045324 |
Appl.
No.: |
10/679,077 |
Filed: |
October 3, 2003 |
Prior Publication Data
|
|
|
|
Document
Identifier |
Publication Date |
|
US 20040068264 A1 |
Apr 8, 2004 |
|
Current U.S.
Class: |
606/92 |
Current CPC
Class: |
A61B
17/1635 (20130101); A61B 17/3468 (20130101); A61B
10/025 (20130101); A61B 17/00234 (20130101); A61B
17/3472 (20130101); A61B 17/3478 (20130101); A61B
2017/0046 (20130101); A61B 2017/00969 (20130101); A61F
2/4601 (20130101); A61F 2002/2835 (20130101); A61F
2002/2892 (20130101) |
Current International
Class: |
A61B
17/58 (20060101); A61F 2/00 (20060101) |
Field of
Search: |
;606/53,86,92,93,94
;604/134,135,152,154,155,97.01,97.02,97.03,187-189,218,224,227
;433/89,90 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Robert; Eduardo C.
Assistant Examiner: Ramana; Anu
Claims
What is claimed is:
1. A method of delivering bone graft material to a bone defect area
in a patient's body through a minimally invasive portal,
comprising: providing an instrument assembly for delivering the
bone graft material to the bone defect area, said instrument
assembly comprising: a bone graft needle for delivery of bone graft
material to the bone defect area, said needle comprising an
elongate bendable tubular delivery member having an open distal end
for positioning at the bone defect area via the minimally invasive
portal providing access to the bone defect area from externally of
the patient's body and having an open proximal end for being
supplied with bone graft material from externally of the patient's
body, said open distal end being aligned with a central
longitudinal axis of said delivery member for discharge of the bone
graft material therefrom towards the bone defect area; and an
elongate flexible penetrating member for receipt within said bone
graft needle, inserting said elongate flexible penetrating member
into said bone graft needle until a distal end of said elongate
flexible penetrating member extends from said open distal end of
said bone graft needle, bending said instrument assembly
intraoperatively while said elongate flexible penetrating member is
inserted in said bone graft needle to thereby provide said bone
graft needle with a selected bent configuration, said selected bent
configuration configured for accessing the bone defect area,
inserting said instrument assembly having said selected bent
configuration through the minimally invasive portal until said
distal end of said bone graft needle operatively reaches the bone
defect area, while maintaining said proximal end of said bone graft
needle external of the patient's body, removing said elongate
flexible penetrating member from said bone graft needle while
retaining said distal end of said bone graft needle at said bone
defect area, said elongate flexible penetrating member being
sufficiently flexible to allow said elongate flexible penetrating
member to be removed from said bone graft needle without
substantially altering said selected bent configuration of said
bone graft needle, and delivering a bone graft material in paste
form to the bone defect area via injection of said bone graft
material through said bone graft needle, said bone graft material
comprising calcium sulfate.
2. The method of claim 1, wherein both said bone graft needle and
said elongate flexible penetrating member are constructed so as to
be easily bendable with minimal crimping so as not to impede fluid
flow through said bone graft needle, yet not easily break.
3. The method of claim 2, wherein said bone graft needle and said
penetrating member are configured to allow bending the instrument
assembly into any number of curved shapes that allow the bone graft
needle to more easily access hard to reach bone defect areas of the
patient's body.
4. The method of claim 3, wherein said elongate flexible
penetrating member is formed of polyether-ether-ketone and has a
stainless steel tip.
5. The method of claim 2, wherein said tubular delivery member is
formed of thin-walled stainless steel of about 6 to about 11
gauge.
6. The method of claim 1, wherein said instrument assembly is bent
to said selected bent configuration by matching said instrument
assembly to a template.
7. The method of claim 1, wherein said instrument assembly is bent
to said selected bent configuration using a cannula bender, said
cannula bender configured for use in bending said bone graft needle
without kinking said bone graft needle.
8. The method of claim 7, wherein said cannula bender is configured
for use in bending said bone graft needle along various radii of
curvature.
9. The method of claim 8, wherein said cannula bender is configured
for use in bending said bone graft needle in more than one
plane.
10. The method of claim 1, wherein said bone graft material
includes demineralized bone matrix.
Description
RELATED APPLICATIONS
This application is related to Assignee's co-pending U.S. patent
application Ser. No. 10/678,701, filed the same day as this patent
application.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention generally pertains to the use of graft
materials for promoting bone growth and, more particularly, to
ported needles for delivering bone graft materials to metaphyseal
compression fractures, other bone voids or other bone defect
areas.
2. Discussion of the Prior Art
In the past, bone graft materials have been delivered to bone
defect areas, such as metaphyseal compression fractures or bone
voids as well as other areas of bone structures having
discontinuities, cavities, recesses or the like (hereinafter
referred to as bone defect areas). Minimally invasive bone graft
procedures are preferred in many cases, and the delivery or
injection of bone graft material to the bone defect areas has been
accomplished using a needle having an open distal end forming an
axial port for delivering the bone graft material to the bone
defect areas from a syringe coupled with the proximal end of the
needle. Such needles have been unable to be precisely positioned,
such as by bending. Therefore, they have not been useful for
ejecting bone graft towards hard to reach locations in the body.
Accordingly, there is room for improvement within the art.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to overcome
the above mentioned disadvantages of the prior art by providing a
bendable bone graft needle particularly useful in minimally
invasive procedures. Another object of the present invention is to
deliver bone graft material to a bone defect area by extruding the
bone graft material through a bendable needle.
The present invention is further generally characterized in a
method of delivering bone graft material to a bone defect area
including the steps of providing an instrument for preparing said
location for said receiving bone graft material, the instrument
comprising: a bone graft needle for delivery of bone graft material
to a bone defect area in a patient's body, the needle comprising:
an elongate bendable tubular delivery member having an open distal
end for positioning at the bone defect area via a minimally
invasive portal providing access to the bone defect area from
externally of the patient's body and having an open proximal end
for being supplied with bone graft material from externally of the
patient's body, the open distal end being aligned with a central
longitudinal axis of the delivery member for discharge of the bone
graft material therefrom towards the bone defect area; and an
elongate flexible penetrating member for receipt within the bone
graft needle.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a perspective view of an instrument assembly
incorporating a bone graft needle according to the present
invention.
FIG. 2 is an exploded side view of the instrument assembly
including a side view of the bone graft needle of the present
invention.
FIG. 3 is a sectional view of a delivery member of the bone graft
needle taken along line A--A of FIG. 2.
FIG. 4 is an exploded side view of an alternative instrument
assembly incorporating an alternative bone graft needle according
to the present invention.
FIG. 5 is a sectional view of the delivery member of the
alternative bone graft needle taken along lines B--B of FIG. 4.
FIG. 6 is a side view of another alternative bone graft needle
according to the present invention.
FIG. 7 is a side view of a further alternative bone graft needle
according to the present invention.
FIG. 8 is a side view of an instrument assembly according to the
present invention, in which the instrument assembly is
bendable.
FIG. 9 shows an exemplary, use of the alternative instrument
assembly of FIG. 8.
FIG. 10 depicts an exemplary construction of bendable penetrating
member 14 for use with the invention.
Other objects and advantages of the present invention will become
apparent from the following description of the preferred
embodiments taken in conjunction with the accompanying drawings,
wherein like parts in each of the several figures are identified by
the same reference characters.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
The present invention relates to a bone graft needle used to
deliver bone graft material to a bone defect area in a patient's
body in a minimally invasive procedure in which the bone defect
area is accessed via a minimal portal or incision. FIGS. 1 and 2
illustrate an instrument assembly 10 comprising a bone graft needle
12 and a penetrating member 14, such as a trocar. The bone graft
needle 12 comprises an elongate tubular delivery member 16
extending distally from a handle 18. The delivery member 16 has an
open distal end 20 communicating with a longitudinal passage 22
extending entirely through the delivery member 16 and the handle
18. A hollow coupling 24 having open distal and proximal ends is
disposed at a proximal end of passage 22 with the interior of the
coupling 24 in communication with the passage 22. The coupling 24
is designed for releasable attachment to a standard syringe and may
be designed as a conventional luer lock coupling. The handle 18 can
have various configurations to facilitate grasping. A proximal end
of the delivery member 16 can be attached to the handle 18 via a
hub 26 or in any desired manner. The proximal end of the delivery
member 16 can extend any desired distance into a passage of the
handle 18 or can extend entirely through the handle. The coupling
24 can be attached to the handle 18 in various ways or may be
formed integrally, unitarily with the handle. The distal end of the
coupling 24 can extend any desired amount into the passage of the
handle 18. Accordingly, it should be appreciated that the
longitudinal passage 22 can be formed in its entirety by the lumen
of delivery member 16, can be formed in part by the lumen of the
delivery member 16 and by a passage in handle 18, or can be formed
in part by the lumen of delivery member 16, a passage in the handle
18 and the interior of the coupling 24.
The delivery member 16, as best shown in FIGS. 2 and 3, has an
external cross sectional diameter or size for insertion through a
minimally invasive portal or incision formed in the patient's body
to access a bone defect area. The delivery member 16 has an
internal cross-sectional diameter or size to receive the
penetrating member 14 therethrough. As shown in FIGS. 1 and 2, the
penetrating member 14 includes an elongate shaft 28 having a tissue
penetrating distal end 30 and having a proximal end attached to a
hub 32. The shaft 28 is insertable in the passage 22 extending
entirely through the bone graft needle and, when the hub 32 is in
abutment with the handle 18, the tissue penetrating distal end 30
protrudes distally from the open distal end 20 of the delivery
member 16 as shown in FIG. 1. The instrument assembly 10 formed
when the penetrating member 14 is inserted in the delivery member
16 can be utilized to form a minimally invasive portal in
anatomical tissue of a patient to establish access to a bone defect
area. The exposed tissue penetrating distal end 30 of the
penetrating member is used to penetrate the anatomical tissue to
introduce the distal end 20 of delivery member 16 at or near the
bone defect area. Thereafter, the penetrating member 14 can be
removed from the bone graft needle 12 leaving the bone graft needle
in place to maintain the thusly formed portal with the handle 18
disposed externally of the patient's body. It should be
appreciated, however, that the bone graft needle 12 can be used
independently of a penetrating member and that the bone graft
needle can be introduced at or near a bone defect area via a
pre-established portal.
The open distal end 20 of delivery member 16 is circumscribed by a
circumferential edge 34 that is provided with one or more
proximally curving indentations as best shown in FIG. 2.
Accordingly, the circumferential edge 34 comprises one or more
distal most edge segments or points and one or more proximal most
edge segments or points spaced proximally from the one or more
distal most edge segments or points. A plurality of radial ports or
openings 36 are formed through delivery member 16 proximally of
circumferential edge 34. As shown in FIG. 3, four radial ports 36
are formed through the wall of delivery member 16 at spaced
locations about a central longitudinal axis 38 of delivery member
16. The ports 36 are shown as being equally spaced about the
central longitudinal axis 38 at 90 degree spaced locations about
the central longitudinal axis 38. It should be appreciated,
however, that the ports 36 can be equally spaced or variably spaced
about the central longitudinal axis. The ports 36 are shown as
having a circular perimetrical configuration, but the ports can
have other perimetrical configurations including oval, elliptical
and various longitudinally elongated perimetrical configurations.
Each port 36 has a longitudinal dimension in a direction parallel
to the central longitudinal axis 38. In the case of ports 36, the
longitudinal dimension corresponds to the diameter of the ports.
Each port 36 begins a distance D proximally of the proximal most
edge segment or point of circumferential edge 34 as shown in FIG.
2. Where the circumferential edge is disposed in its entirety in a
plane perpendicular to the central longitudinal axis 38, the
proximal most edge segment or point will be disposed in the plane
perpendicular to the central longitudinal axis 38 as described
below for FIGS. 6 and 7. Distance D may be in the range of 0.020
inch to 0.275 inch. For delivery member 16 having ports 36 that are
0.063 inch in diameter, the longitudinal dimension for ports 36 is
also 0.063 inch and a preferred range for distance D is 0.0505 inch
to 0.0805 inch. FIG. 2 illustrates a removable tubular sheath 40
that may be disposed over the delivery member 16 prior to use.
In a preferred embodiment for bone graft needle 12, the needle is a
4 inch needle with delivery member 16 made of 304 stainless steel
or other rigid biocompatible material and having a J-type
cannulated distal end or tip; the delivery member is 0.185 inch in
diameter; the radial ports 36 are 0.063 inch in diameter with
centers at 90.degree. (+or -2.0.degree.) spaced locations about the
central longitudinal axis; and the centers of ports 36 are located
0.082 inch (+0.030 inch, -0.000 inch) proximally of the proximal
most edge segment or point of circumferential edge 34. The needle
12 may be a JAMSHIDI-type needle with a luer-lock coupling or
connector.
The open distal end 20 defines an axial or longitudinal port for
delivery member 16 from which a bone graft material is discharged
from delivery member 16 in an axial or longitudinal direction. The
radial ports 36 permit bone graft material to be discharged from
delivery member 16 in a direction radial to the central
longitudinal axis 38 so that bone graft material is discharged
radially simultaneously with the axial discharge.
In a method according to the present invention, the distal end 20
of delivery member 16 is introduced at or near a bone defect area
in a patient's body via a minimally invasive portal providing
access to the bone defect area from externally of the patient's
body. As discussed above, the bone graft needle 12 may be assembled
with a penetrating member to form an instrument assembly that may
be used to form the portal. Visualization of the bone defect area
may be accomplished using a remote viewing device, such as a
fluoroscope or x-ray device, as conventionally utilized in
minimally invasive procedures. FIG. 2 illustrates a bone segment 42
having a bone defect area 44 to be supplied with a bone graft
material delivered via the bone graft needle 12. The bone defect
area 44 may include metaphyseal compression fractures, bone voids,
discontinuities, cavities, recesses, non-unions or the like. The
bone graft material to be delivered to the bone defect area may be
any synthetic or tissue-based material that promotes bone growth
and may be provided in paste form. Representative bone graft
materials include calcium sulfate, as represented by the
OSTEOSET.RTM. bone graft substitute of Wright Medical Technology,
Inc., Allomatrix.RTM. and MIIG.TM. 115 of Wright Medical
Technology, Inc., and demineralized bone matrix. The bone graft
material is supplied to the bone graft needle 12 via a conventional
syringe coupled with the coupling 24. With the handle 18 disposed
externally of the patient's body, the syringe containing the bone
graft material is coupled with coupling 24. The distal end 20 of
delivery member 16 is positioned at or adjacent the bone defect
area 44 and, depending on the size of the bone defect area, the
distal end 20 may be positioned within the bone defect area. With
the distal end 20 properly positioned, a plunger of the syringe is
depressed to fill the passage 22 with the bone graft material.
Depressing the plunger of the syringe pressurizes the bone graft
material in passage 22 causing the bone graft material to be
simultaneously discharged axially through distal end 20 and
radially through the ports 36 to fill the bone defect area 44. In
the case of delivery member 16, the bone graft material is
discharged simultaneously in five directions, i.e. in a first
direction axially or longitudinally through distal end 20 and in
second, third, fourth and fifth radial directions through ports 36,
respectively. In the event that the distal end 20 is in abutment
with bone or other anatomical tissue, plugging or clogging of the
delivery member 16 is avoided since discharge of the bone graft
material continues through ports 36. In addition, back pressure is
reduced for easier injection of the bone graft material since
resistance to injection is reduced due to the multi-directional
discharge provided by opening 20 and ports 36. The arrangement of
ports 36 along the circumference of delivery member 16 permits
radial discharge and distribution of the bone graft material and
allows the bone defect area to be filled radially as well as from
the distal end 20 of the delivery member. The distribution of ports
36 along the circumference of the delivery member allows the bone
defect area to be filled in a range of 360 degrees around the
delivery member. Also, the circumferential distribution of the
ports 36 provides a more even and more balanced distribution of
bone graft material to the bone defect area. Once the bone defect
area 44 has been sufficiently supplied or filled with the bone
graft material, the needle 12 is removed from the patient's body
through the portal. The bone graft material remains in the
patient's body to promote bone growth or regeneration.
FIG. 4 illustrates an alternative instrument assembly 110
comprising a bone graft needle 112 and a penetrating member 114.
The instrument assembly 110 is similar to instrument assembly 10
except that the bone graft needle 112 and the penetrating member
114 are shorter in length than the bone graft needle 12 and
penetrating member 14. Accordingly, it should be appreciated that
the bone graft needle, as well as the penetrating member, can be
provided in different lengths depending on the length needed to
access the bone defect area. The bone graft needle 112 also differs
from the bone graft needle 12 in that the delivery member 116 is of
smaller external diameter than the delivery member 16. It should be
appreciated, therefore, that the delivery members of the bone graft
needles can be provided in various diametric sizes. Of course, the
shafts of the penetrating members can also be provided in various
diametric sizes depending on the anatomical tissue to be
penetrated. The radial ports 136 for delivery member 116 differ
from the ports 36 in that the ports 136 are smaller in
diameter.
In a preferred embodiment for bone graft needle 112, the external
diameter of delivery member 116 is 0.115 inch; the ports 136 have a
diameter of 0.047 inch with centers at 90.degree. (+or
-2.0.degree.) spaced locations about the central longitudinal axis
138; distance D may be in the range of 0.020 inch to 0.275 inch and
is preferably in the range of 0.082 inch to 0.112 inch; the needle
112 is a 6 cm needle with delivery member 116 made of 304 stainless
steel or other rigid biocompatible material and having a J-type
cannulated distal end or tip; and the centers of ports 136 are
located 0.082 (+0.030 inch, -0.000 inch) proximally of the proximal
most edge segment or point of circumferential edge 134. The needle
112 may be a JAMSHIDI-type needle with a luer-lock coupling or
connector.
FIG. 6 is illustrative of a bone graft needle 212 in which the
delivery member 216 has a distal end 220 with a circumferential
edge 234 disposed in a plane perpendicular to the central
longitudinal axis 238. Distance D for delivery member 216 is
defined from the plane of edge 234 to where the ports 236 begin
proximally of edge 234.
The bone graft needle 312 illustrated in FIG. 7 is representative
of a delivery member 316 having radial ports 336 that are not
circular in perimetrical configuration. The radial ports 336 are
formed as elongate slots in delivery member 316, and the slots
begin a distance D proximally of the circumferential edge 334,
which is disposed in a plane perpendicular to central longitudinal
axis 338.
FIG. 8 shows an alternative embodiment of an instrument assembly 10
according to the invention. As with the main embodiment of the
invention, instrument assembly 10 comprises a bone graft needle 12
and a penetrating member 14, such as a trocar. While the bone graft
needle 12 is shown as not having radial ports 36, that is because
radial ports are not important to this aspect of the invention and
may be omitted.
However, in this embodiment, both bone graft needle 12 and
penetrating member 14 are constructed so as to be easily bendable
with minimal crimping (to not impede fluid flow there through), yet
not easily break. This allows the user to bend the combined
instrument 10 into any number of curved shapes that ultimately
allow the bone graft needle 12', 12'' to more easily access hard to
reach areas of the body.
An exemplary construction of bone graft needle 12 so that it is
easily bendable with minimal crimping, yet not easily break is
forming tubular delivery member 16' out of thin-walled stainless
steel, of approximately 6 11 gauge.
An exemplary construction of penetrating member 14 so that it is
easily bendable with minimal crimping, yet not easily break is
shown in FIG. 10. This exemplary construction comprises forming
elongate shaft 28' out of either solid or hollow
PolyEtherEtherKetone (PEEK), with a stainless steel tip 30' for
body member penetrating ability. Penetrating member 14 must be
flexible enough to allow for removal from the needle 12 after the
needle 12 has been bent.
One hard to reach area in which this aspect of the invention is
useful, is the tibial plateau 400, such as shown in FIG. 9. Tibial
plateau 400 is shown as having a fracture 410 that results in a
small bone fragment 415 that needs to be secured in position.
A doctor, after reviewing x-rays or by any other known method, can
judge the best instrument 10 approach for introducing bone graft
material to the fracture area. Then, intra-operatively, the doctor
can bend instrument 10 to the desired curvature, by either matching
it to a template or by trial and error based upon experience.
Penetrating member 14 will preferably be positioned within bone
graft needle 12 during the bending process to assure a matching
curvature between the two components. Any device or method can be
used for bending instrument 10, for example, that shown in U.S.
Pat. No. 6,368,335, whose contents are incorporated by reference
herein.
The instrument 10 is inserted into the lower leg L and tibia T and
the tip of the instrument brought next to the fracture 410.
Penetrating member 14 is then removed from bone graft needle 12.
Syringe 445, filled with bone graft material 450 is connected to
bone graft needle 12 via conventional methods, and pumped into the
fracture site, as previously described.
Inasmuch as the present invention is subject to many variations,
modifications and changes in detail, it is intended that all
subject matter discussed above or shown in the accompanying
drawings be interpreted as illustrative only and not be taken in a
limiting sense.
* * * * *